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ADDRESSING THE NEGLECTED DISEASES

TREATMENT GAP

HEARING

BEFORE THE

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, 

GLOBAL HUMAN RIGHTS, AND 

INTERNATIONAL ORGANIZATIONS

OF THE

COMMITTEE ON FOREIGN AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED THIRTEENTH CONGRESS

FIRST SESSION

JUNE 27, 2013

Serial No. 113–76

Printed for the use of the Committee on Foreign Affairs

(

Available via the World Wide Web: http://www.foreignaffairs.house.gov/ or

http://www.gpo.gov/fdsys/

(II)

COMMITTEE ON FOREIGN AFFAIRS 

EDWARD R. ROYCE, California, Chairman 

CHRISTOPHER H. SMITH, New Jersey 

ILEANA ROS-LEHTINEN, Florida 

DANA ROHRABACHER, California 

STEVE CHABOT, Ohio 

JOE WILSON, South Carolina 

MICHAEL T. MCCAUL, Texas 

TED POE, Texas 

MATT SALMON, Arizona 

TOM MARINO, Pennsylvania 

JEFF DUNCAN, South Carolina 

ADAM KINZINGER, Illinois 

MO BROOKS, Alabama 

TOM COTTON, Arkansas 

PAUL COOK, California 

GEORGE HOLDING, North Carolina 

RANDY K. WEBER SR., Texas 

SCOTT PERRY, Pennsylvania 

STEVE STOCKMAN, Texas 

RON DESANTIS, Florida 

TREY RADEL, Florida 

DOUG COLLINS, Georgia 

MARK MEADOWS, North Carolina 

TED S. YOHO, Florida 

LUKE MESSER, Indiana 

ELIOT L. ENGEL, New York 

ENI F.H. FALEOMAVAEGA, American 

Samoa 

BRAD SHERMAN, California 

GREGORY W. MEEKS, New York 

ALBIO SIRES, New Jersey 

GERALD E. CONNOLLY, Virginia 

THEODORE E. DEUTCH, Florida 

BRIAN HIGGINS, New York 

KAREN BASS, California 

WILLIAM KEATING, Massachusetts 

DAVID CICILLINE, Rhode Island 

ALAN GRAYSON, Florida 

JUAN VARGAS, California 

BRADLEY S. SCHNEIDER, Illinois 

JOSEPH P. KENNEDY III, Massachusetts 

AMI BERA, California 

ALAN S. LOWENTHAL, California 

GRACE MENG, New York 

LOIS FRANKEL, Florida 

TULSI GABBARD, Hawaii 

JOAQUIN CASTRO, Texas

AMY PORTER, Chief of Staff THOMAS SHEEHY, Staff Director

JASON STEINBAUM, Democratic Staff Director 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND

INTERNATIONAL ORGANIZATIONS

CHRISTOPHER H. SMITH, New Jersey, Chairman 

TOM MARINO, Pennsylvania 

RANDY K. WEBER SR., Texas 

STEVE STOCKMAN, Texas 

MARK MEADOWS, North Carolina 

KAREN BASS, California 

DAVID CICILLINE, Rhode Island 

AMI BERA, California 

(III)

C O N T E N T S 

Page

WITNESSES 

Lee Hall, M.D., Ph.D., chief, Parasitology and International Programs Branch, 

Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services ................................................................. 5

Jesse Goodman, M.D., chief scientist, Food and Drug Administration, U.S. 

Department of Health and Human Services ...................................................... 21

Peter J. Hotez, M.D., Ph.D., president, Sabin Vaccine Institute ......................... 52

Jay Siegel, M.D., chief biotechnology officer and head of scientific strategy 

and policy, Johnson & Johnson ........................................................................... 69

Alix Zwane, Ph.D., executive director, Evidence Action ....................................... 84

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

Lee Hall, M.D., Ph.D.: Prepared statement ........................................................... 8

Jesse Goodman, M.D.: Prepared statement ........................................................... 24

Peter J. Hotez, M.D., Ph.D.: Prepared statement ................................................. 58

Jay Siegel, M.D.: Prepared statement ................................................................... 72

Alix Zwane, Ph.D.: Prepared statement ................................................................ 87

APPENDIX 

Hearing notice .......................................................................................................... 100

Hearing minutes ...................................................................................................... 101

Written response from NIAID to question submitted for the record by the 

Honorable Christopher H. Smith, a Representative in Congress from the 

State of New Jersey, and chairman, Subcommittee on Africa, Global Health, 

Global Human Rights, and International Organizations ................................. 102

(1)

ADDRESSING THE NEGLECTED DISEASES 

TREATMENT GAP 

THURSDAY, JUNE 27, 2013

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS,

COMMITTEE ON FOREIGN AFFAIRS,

Washington, DC. 

The subcommittee met, pursuant to notice, at 2:06 p.m., in room 

2200, Rayburn House Office Building, Hon. Christopher H. Smith 

(chairman of the subcommittee) presiding. 

Mr. SMITH. Good afternoon. 

Today’s hearing will examine the neglected diseases that affect 

a relatively small but a significant number of children around the 

world. These diseases are not only debilitating for their victims but 

far too often fatal when untreated. Such diseases largely impact 

poor people in poor countries. 

They are not only small in numbers but those folks who are unable to pay market prices for treatments and are unlikely to lead 

the social movements to force action on their respective diseases. 

That means that research on detection, vaccines, and drug treatment for their ailments do not receive the priority that diseases 

such as HIV/AIDS, often seen in pandemic levels, are given. 

The World Health Organization has identified 17 neglected tropical diseases, or NTDs. The list ranges from Chagas to rabies to 

leprosy to dengue fever. However, there are others not on the list 

of 17 diseases that also receive less attention. These include such 

diseases as polio and smallpox, which have largely been eliminated 

from the planet, and fatal, fortunately rare NTDs such as kuru and 

Ebola. 

I would note parenthetically, back in the early 1980s, when I authored what was known as the Child Survival Reauthorization 

Amendment for some $50 million, I traveled to El Salvador, and 

the polio vaccine was given to upwards of 200,000 children, along 

with other immunizations to guard against pertussis, diphtheria, 

and other leading killers of children. Thankfully, some of those diseases are largely gone, but some, sadly, are making a comeback. 

I would also point out that we have had hearings in this subcommittee and I have introduced legislation to focus on another 

problem, particularly in Africa, of the infection-based hydrocephalic 

condition that is hurting so many children in places like Uganda. 

I actually went to CURE International’s clinic in Uganda and 

saw children who got the treatment. Dr. Benjamin Warf has develVerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL
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oped it out of Harvard. There are no shunts involved, and these 

kids went from very large painful conditions in their head, water 

on the brain, to very healthy children. And at least 5,000 kids have 

been saved there. We have been asking, urging, begging practically, 

that USAID do something administratively to try to address that 

issue. 

This hearing will consider the current U.S. Government’s handling of these and other neglected diseases to determine what more 

can be done or should be done to address this situation. Current 

U.S. law favors research on those diseases threatening the American homeland, but in today’s world diseases can cross borders as 

easily as those affected by them or the products imported from the 

United States. 

For example, Chagas is most prevalent in Latin America, but it 

has been identified in patients in Texas. And cases of dengue fever 

have recently been reported in Florida. We cannot afford to assume 

that what may have seemed to be an exotic disease only happens 

to people in other countries. 

Ten years ago, West Nile virus, another NTD, was not seen in 

the United States or anywhere else outside of the East African nation of Uganda, but in less than a decade it has spread across the 

country and much of the rest of the world. Last year, 286 people 

died from West Nile virus in the United States alone. As recently 

as the mid-1990s, this disease was seen only sporadically and was 

considered a minor risk for human beings. 

Generally, NTDs affect the health of the poor in developing countries where access to clean water, sanitation, and health care is 

limited. Roughly 2 billion people are being treated for at least one 

NTD, although most individuals are infected with several NTDs at 

once. 

Several NTDs are difficult to control by drug treatment alone because of their complicated transition cycles that involve nonhuman 

carriers, such as insects. Furthermore, some of the drugs have significant side effects, including death, and cannot be used by young 

children or pregnant women. 

A study done in 2001 found that research and development of 

drugs to treat infectious diseases had ground to a near standstill. 

From 1975 to 1999, the report stated 1,393 new drugs were 

brought to the market globally, but only 16, or 1.1 percent, were 

for tropical diseases, including malaria and even tuberculosis, although these diseases represented 12 percent of the global disease 

burden. 

A 2012 update of that study found that the gap between the percentage of research and development of NTDs and their percentage 

of the global disease burden had narrowed, but there is still a long 

way to go to reach an adequate balance. 

Of the 756 new drugs approved between 2000 and 2011, 29, or 

3.8 percent, were for neglected diseases, although the global burden 

of such diseases was estimated at 10.5 percent. Of these, only four 

were new chemical creations, three of which were for malaria, but 

none for tuberculosis or neglected tropical diseases. 

It is unprofitable for companies to create treatments for diseases 

with few victims, and especially for few paying victims, and no certain way to recover research and development costs. Our heart goes 

3

out to those who suffer from these neglected diseases, and we want 

our Government to speed up research and development in cooperation with universities and private companies. 

However, research and development takes time and effort and 

costs money that private companies perhaps cannot easily justify 

to their stockholders, including many of us, without incentives. We 

are here today to consider such incentives and to look at the system in place to forge successful efforts to deal with NTDs. 

We have with us representatives from the National Institutes of 

Health, which was established to understand, treat, and ultimately 

prevent the many infectious immunologic and allergic diseases that 

threaten millions of human lives. Their government partner in the 

system for developing solutions to the problem of NTDs and other 

diseases, of course, is the Food and Drug Administration, which, 

among other responsibilities, is charged with protecting and promoting public health through the regulation and supervision of prescription and over-the-counter pharmaceutical medications, vaccines, and biopharmaceuticals. 

Also joining us today are representatives from a network specializing in providing medicines at the lowest possible price to those 

suffering from NTDs, a major pharmaceutical company that develops new drugs for the treatment of diseases, rare and otherwise, 

and a new organization seeking to extend the benefits of proven 

interventions to improve the lives of the poor in developing countries. 

If a solution to the gap between existing research and development and successful strategies to meet the challenges of NTDs is 

to be found, it will take the collaboration of organizations represented here today, who are all leaders in their field. 

I would like to yield to Dr. Bera and then to my friend, Mr. 

Meadows. 

Mr. BERA. Thank you, Chairman. 

And I want to applaud you for having a series of hearings on the 

importance of emerging diseases and the importance of developing 

new therapeutics and so forth. Return on investment can’t just be 

measured in dollars returned and dividends. Return on investment 

also is on relief of suffering, lives saved, and so forth, and those 

are clearly very important measures. And I applaud you for championing that and having these hearings. 

You know, I look at this issue as a physician and have to look 

at it from that perspective of global health. I am excited about 

hearing the testimony. It is not going to be an easy challenge, elevating the consciousness. And, you know, when I look at a number 

of the neglected diseases—you know, the last I discussed this was 

when I took parasitology in medical school. 

But having recently, you know, a few years ago, traveled to Nicaragua with our medical students from UC-Davis to work out there, 

it is very, you know—we were dealing with a dengue fever epidemic. And, you know, I am going to be curious and certainly ask 

some questions about developing better surveillance mechanisms, 

as well, so we are actually better capturing the burden of disease, 

especially with emerging diseases. 

And, you know, I am excited about this testimony. So, again, that 

is the doctor in me, and that is the public health side of me. 

4

So, with that, I will yield back. And, again, I am looking forward 

to the testimony. 

Mr. SMITH. Thank you. 

Mr. Meadows? 

Mr. MEADOWS. Thank you, Mr. Chairman. 

And thank each of you for coming today. 

I want to echo what my colleague, Dr. Bera, just said. The chairman has been a strong, unflinching voice for those that, many 

times, never have a voice here on Capitol Hill. 

And it is an honor to serve with you. 

And I certainly look forward to hearing your testimony as we 

look at this. They have called votes, so I am going to keep my opening remarks brief and hear from the experts here, but thank you 

so much for being willing to highlight this and help us prioritize 

and help identify what we can do legislatively and certainly from 

an appropriations standpoint to make your job easier. Thank you. 

With that, I will yield back, Mr. Chairman. 

Mr. SMITH. Thank you very much, Mr. Meadows. 

I would like to introduce our very distinguished panelists. We do 

have a vote under way, and I deeply apologize for the inconvenience. I thought I would introduce you and then we would be in 

brief recess. And hopefully several other members will come back 

to hear your testimony so there is no rush. 

So let me introduce our very distinguished panel, beginning with 

Dr. Lee Hall, who is chief of Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases at 

the National Institute of Allergy and Infectious Diseases, part of 

the National Institutes of Health. He oversees multiple programs 

that support basic translational and clinical research in development in parasites and vectors responsible for transmission of 

parasites. 

He has developed and provided oversight for a range of research 

programs and has served on numerous committees for Federal 

international activities, including vaccine R&D and global health. 

Dr. Hall has also chaired and participated in numerous scientific 

symposia and national and international meetings. 

And our next witness will then be Dr. Jesse Goodman, who is the 

chief scientist of the FDA. He has a broad responsibility for and engagement in strategic leadership and coordination of FDA’s crosscutting scientific and public health efforts, including for public 

health preparedness and medical countermeasures. He led the 

2009 H1N1 pandemic response and the medical countermeasure review for the Food and Drug Administration. 

Prior to joining FDA, he was a professor of medicine and chief 

of infectious diseases at the University of Minnesota, where he directed multihospital infectious disease research. He has authored 

numerous scientific papers and has been elected to the American 

Society for Clinical Investigation and to the Institute of Medicine. 

We will stand in brief recess and then continue with the hearing. 

[Recess.] 

Mr. SMITH. The committee will resume its meeting. 

And I would like to start with Dr. Hall, if you could, and then 

go to Dr. Goodman. Thank you. 

I do apologize for that very long delay with the votes. 

5

Let me just say, vice chairman of the committee, Mr. Weber, do 

you have anything to add? 

Mr. WEBER. I am good to go. 

Mr. SMITH. Okay. 

STATEMENT OF LEE HALL, M.D., PH.D., CHIEF, PARASITOLOGY 

AND INTERNATIONAL PROGRAMS BRANCH, DIVISION OF 

MICROBIOLOGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Dr. HALL. Mr. Chairman and members of the committee, thank 

you for the opportunity to discuss the global and domestic public 

health threat of neglected tropical diseases, or NTDs, which affect 

millions of people worldwide and significant numbers in the United 

States. 

I am chief of the Parasitology and International Programs 

Branch of the National Institute of Allergy and Infectious Diseases, 

or NIAID, at the National Institutes of Health. I will now present 

a summary of my written testimony, which has been submitted for 

the record. 

NIAID supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases, including the great global killers HIV/AIDS, tuberculosis, and malaria; emerging infectious pathogens, such as West Nile virus, 

Ebola virus, and the novel coronavirus emerging in the Middle 

East; and reemerging infectious diseases, such as dengue fever. 

NIAID is committed to improving public health through support 

of basic research, identification of drug and vaccine targets, preclinical testing, and clinical trials. NIAID also offers a broad array 

of preclinical and clinical resources for researchers to help generate 

the evidence necessary for the review and eventual approval and 

licensure of diagnostics, therapeutics, and vaccines by the Food and 

Drug Administration. 

The World Health Organization has identified 17 infectious diseases as NTDs. These NTDs are concentrated in impoverished populations in the developing world. Among them are several wellknown diseases such as dengue fever, African sleeping sickness, 

and Hansen’s disease, or leprosy. 

The global burden of these diseases is high. Over 1 billion people 

suffer from one or more NTDs, which exact an extraordinary 

human and economic cost. NTDs both result from and contribute 

to poverty. And they are often co-endemic with other infectious diseases, such as HIV/AIDS, tuberculosis, and malaria. 

Treatment and prevention options for NTDs are currently limited. NIAID is working to strengthen the research and development 

pipeline for NTDs by leveraging existing clinical research infrastructure and resources. For example, the NIAID Tropical Medicine 

Research Centers are designed to facilitate research on the cause, 

diagnosis, prevention, and treatment of NTDs in countries where 

they are endemic. 

NIAID also facilitates research on NTDs by providing access to 

resources, including repositories of genomic sequences and samples 

of parasites, transmission vectors, and hosts, as well as services for 

6

early-stage development of NTD countermeasures. NIAID enters 

into public-private partnerships with a variety of organizations to 

share the cost and risk of developing new and improved vaccines, 

treatments, diagnostics, and vector control strategies. 

But time does not permit me to describe all of the work we are 

doing in this area. I will now highlight recent NIAID-supported scientific discoveries on several important NTDs. 

Dengue fever affects millions of people every year and is reemerging as a disease of public health importance in the Americas, 

including endemic transmission in Puerto Rico and locally acquired 

cases in Florida. The disease is caused by mosquito-borne viruses 

that produce high fever, joint and muscle pain, and, in severe 

cases, death. 

NIAID is funding studies on dengue fever, including development 

of rapid diagnostic tests, therapies, and vaccines. Recently, NIAID 

scientists identified TetraVax, a promising vaccine candidate that 

has been licensed by manufacturers in Brazil, India, and Vietnam. 

Phase two clinical trials to further evaluate TetraVax will begin 

soon in Brazil and Thailand. If successful, this vaccine could be instrumental in limiting the spread of dengue fever worldwide. 

Seven million to eight million people have Chagas disease. As 

many as 300,000 people in the United States may have Chagas disease, most having been infected in endemic countries and then 

traveling to the United States. The growing pipeline of treatments 

for Chagas disease includes a promising drug candidate, K777. 

NIAID-funded basic research identified this drug. NIAID also supported preclinical studies and will continue clinical development of 

K777 to determine its safety and efficacy for treating Chagas disease. NIAID-supported researchers also are exploring innovative 

designs for Chagas disease vaccines. Such interventions are showing great promise in limiting Chagas disease worldwide. 

Schistosomiasis is a chronic disease caused by parasitic worms. 

Though its mortality is relatively low, tens of millions of people 

worldwide suffer chronic and debilitating consequences. NIAID 

supported the genome sequencing of multiple species of worms responsible for different forms of schistosomiasis, including one that 

causes a form associated with bladder cancer. This genomic information has helped to identify potential cancer-causing genes in this 

organism as well as targets for new antiparasitic therapies. 

NIAID also pursues the development of schistosomiasis vaccines. 

Recently, NIAID-supported researchers identified a promising vaccine candidate, and NIAID is partnering with a small business 

under NIH’s Small Business Innovation Research Program to further preclinical development of this vaccine. Together with the Bill 

and Melinda Gates Foundation, NIAID sponsored a meeting this 

year to assess schistosomiasis vaccine candidates and provide guidance for future vaccine research. 

Hansen’s disease, also known as leprosy, is a chronic bacterial 

disease that often leads to lifelong disability. Hansen’s disease has 

long been associated with social stigma and discrimination. Nearly 

230,000 new cases of Hansen’s disease were identified globally in 

2010. In the United States, 213 cases were reported in 2009, including some thought to result from transmission to humans from 

armadillos. 

7

NIAID research efforts on Hansen’s disease are focused on early 

detection, prevention of nerve damage, and discovery of emerging 

drug resistance. Armadillos, the only animal known to be susceptible to Hansen’s disease, are an important tool for research on this 

disease. NIAID has supported the only globally available research 

reagents from Hansen’s disease propagated in armadillos and also 

supported the development of the armadillo as an animal model to 

evaluate the efficacy of new drugs and vaccines. 

In conclusion, NIAID will continue its longstanding investment 

in improved diagnostics, therapeutics, and vaccines to control the 

global and domestic threat of NTDs by capitalizing on public-private partnerships and fruitful collaborations with academia, nonprofit organizations, and industry. 

Thank you for the opportunity to testify about this important 

issue. I would be pleased to answer the committee’s questions. 

Mr. SMITH. Thank you very much, Dr. Hall. 

[The prepared statement of Dr. Hall follows:]

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Mr. SMITH. Dr. Goodman? 

STATEMENT OF JESSE GOODMAN, M.D., CHIEF SCIENTIST, 

FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Dr. GOODMAN. Mr. Chairman and members of the subcommittee, 

I am Jesse Goodman, chief scientist at the Food and Drug Administration. I, too, want to thank you for this opportunity to discuss 

rare and neglected diseases and the progress that is being made to 

accelerate development of products needed to diagnose, prevent, 

and treat them. 

Rare and neglected diseases taken together are a major public 

health concern. For example, in the United States, rare diseases together affect 30 million Americans. Around the world, most often 

in impoverished areas, over 1 billion people are affected by at least 

one neglected disease. As a practicing infectious disease physician, 

much like you have mentioned, Dr. Bera, I have personally witnessed the devastating toll of these diseases on humans infected 

with them. 

This hearing is also a great opportunity to remind our Nation, 

as the chairman did, that infectious diseases know no boundaries 

and that threats to health anywhere are threats to everyone. For 

example, in recent months, we have seen outbreaks of avian flu in 

China and of coronavirus, a SARS-like coronavirus in the Middle 

East that have alarmed the world and spurred preparedness efforts 

here in the United States. 

As you also noted, in 2010 our colleagues at CDC reported dengue, a mosquito-borne infection common throughout the world, for 

the very first time in United States residents who had not traveled 

abroad. So this is what we would consider a tropical disease now 

occurring in our country. Dengue is also a potential threat to blood 

safety, as also is Chagas disease. So there are both compelling humanitarian reasons but also U.S. national security and health reasons to work together to protect against these diseases. 

For all of these reasons, we engage in close collaborations to accelerate development and availability of needed products. I also 

want to recognize the innovative efforts of many in industry and 

nongovernmental organizations such as those that Drs. Siegel, 

Zwane, and Hotez are going to talk about here today. 

Our efforts at FDA depend on strong science and a highly interactive review process and utilize a variety of novel tools and incentives. While the need remains great, these approaches have led to 

important successes, particularly in rare diseases, and I am optimistic that many of them can be applied to neglected diseases. 

The Orphan Drug Act provides important incentives to encourage 

development of drugs to treat rare diseases. Neglected diseases almost always will qualify for orphan drug designation. When drug 

sponsors apply for and obtain orphan drug designation, they get a 

number of benefits: Tax credits and grant opportunities for clinical 

trials, waivers of their user fees, and a period of market exclusivity 

if the drug is approved. 

The FDA Safety and Innovation Act, passed by Congress just last 

year, provides additional new incentives for certain drugs intended 

22

to treat serious or life-threatening infections, including drug-resistant infections. So we are very interested in that. 

Just this week, we issued new draft guidance for industry that 

puts together all of our different programs for expediting development of products for serious and life-threatening conditions. They 

are discussed in detail in my written testimony, but one program 

I wanted to highlight is what we call accelerated approval, which 

allows approval of a drug or vaccine based on what we call a surrogate endpoint, such as a lab finding or a clinical finding, that is scientifically shown to be likely to predict an ultimate benefit on a serious outcome. This can allow much earlier assessment and approval of likely effectiveness, particularly for chronic diseases. 

FDA also recognizes the importance of global collaboration and 

engagement. While it is a resource challenge, FDA, NIH, and CDC 

are very involved in global health. We played an important role 

working together in developing what is called the Global Vaccine 

Action Plan, which was recently adopted by the World Health Assembly. Lee and I both worked on that. 

FDA is also a key partner with the WHO in what we call 

diagnostics and vaccine prequalification programs. We help them 

evaluate products for global use, which is particularly important in 

collaborative efforts to build regulatory capacity in other parts of 

the world. We work, for example, at something called the African 

Vaccine Regulatory Forum. The idea here is to help our colleagues 

in regulatory agencies around the world and potentially get access 

to countries that need products sooner. 

It is also important to make sure, though, that for the products 

we have now that people have access to them and that they are 

safe. And there is a big problem with the substandard and counterfeit medicines that are common in many parts of the world. For example, malaria kills more than 600,000 people globally every year, 

mostly children, but compromised or fake antimalarial medicines 

have been found to make up 10–50 percent of the drug supply in 

a number of countries. Such medicines will not cure patients. 

Sometimes their use results in death or serious injury, and they 

can lead to resistant strains. 

This April, FDA announced a unique public-private partnership 

to identify counterfeit or substandard antimalarial medications 

with the development and testing of a device developed in our laboratories called CD–3, or the Counterfeit Detection Device. This 

partnership includes the Skoll Global Threats Fund, the United 

States Pharmacopeia, our colleagues at NIH and CDC, the President’s Malaria Initiative, as well as the Corning company. 

To further promote development or treatments for rare and neglected diseases, we also strive to bridge the gap between basic scientific research and getting to products that people can use. This 

gap, in fact, can be filled through enhanced regulatory science, for 

example, the development of those surrogate endpoints I mentioned 

that can speed product development, or through disease models. 

One example, just to mention one of many, is a new model developed at FDA to develop drugs and vaccines against leishmaniasis, 

which infects 12 million people around the world. 

Another remarkable accomplishment is the development of a new 

vaccine to protect people against serogroup A meningitis, which 

23

causes devastating epidemics in Africa. Working through a unique 

public-private partnership, the Meningitis Vaccine Project, FDA 

scientists developed and made available an innovation that allowed 

a safe and effective meningitis vaccine to be manufactured efficiently at greatly reduced cost. As a result, over 100 million people 

in Africa have now been vaccinated, and that disease has been 

beaten back dramatically. 

While much remains to be done, recent FDA approvals highlight 

the success and promise of these kinds of proactive approaches. For 

example, Sirturo, or bedaquiline, was granted accelerated approval 

as an orphan drug just this last December to be used as part of 

combination therapy for multidrug-resistant pulmonary tuberculosis when there are no other treatment options. Similarly, FDA 

used expedited approaches to approve Kalydeco to treat a rare form 

of cystic fibrosis. This drug was approved within 3 months, a near 

record time. 

So, in conclusion, thank you for this opportunity to testify about 

our work with others in combating rare and neglected diseases. 

Your engagement and support, including the strong science at 

FDA, has been and will remain important in helping to solve problems in developing these needed products. I am frankly optimistic 

that, with so many people working together so well, we will continue to see progress. 

I look forward to working with you and welcome your questions. 

Mr. SMITH. Dr. Goodman, thank you so very much. 

[The prepared statement of Dr. Goodman follows:]

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Mr. SMITH. And Dr. Bera, I know, has to leave. 

But thank you so much for both of you for your full statements, 

which will be made a part of the record. And I think it will provide 

some very useful guidance for this committee. And we look forward 

to collaborating with you going forward on how we might be helpful 

as a subcommittee on these issues. 

Just a couple of questions. Again, I will submit many more, but 

because this committee was in recess for almost an hour, I won’t 

keep you much longer. 

But you mentioned the counterfeiting issue. We have heard a 

number of reports that artemisinin, that there are concerns that its 

efficacy, particularly in some parts of Southeast Asia, is becoming 

questionable because of wrongful use but also maybe because of 

some of the bogus medicines that are being proffered out there. 

How big of a counterfeiting problem is it? Who are making the 

counterfeit drugs? Is it coming out of China? Is it coming from people in other countries, from the U.S.? Where are these drugs coming from? 

Dr. GOODMAN. Well, you know, I would like to get back to you 

with more detailed data on issues like what we found in terms of 

sources of counterfeit drugs. It may, in fact, not always be apparent, but what I can tell you is it is a big problem. 

As I mentioned, most of the studies were in Africa, but there are 

studies also in Southeast Asia that show substantial percentages of 

counterfeit or what are often substandard antimalarial medicines. 

They may contain lower amounts; they may contain other contaminants that are potentially harmful to health. Sometimes they are 

an antimalarial medicine but they are the wrong one, so that they 

may not work in an infection that would be resistant to the medicine the doctor doesn’t know they are actually administering. 

So this is a big problem. And our device is one approach. It can 

be used, you know, remotely in the field; it is a handheld device. 

It appears to be pretty effective, although it is undergoing field 

testing now. 

You know, in addition, FDA has recently been working with 

INTERPOL and others to really crack down on Internet sales 

through fake Internet pharmacies and outfits. I suspect some of 

those fuel a lot of the bad product that is out there. 

But we are really gratified that people have recognized the importance of this as a public health problem. As an infectious disease person, I will say misuse of antibiotics or use of antibiotics 

that are substandard or subpotent is very concerning, both because 

it hurts patients and it does contribute to this problem of increasing drug resistance that we are seeing. 

Mr. SMITH. You note in your testimony the—or Dr. Hotez, I 

should say, notes in his testimony that, when you talk about stunting, that tropical diseases is also a major contributor to stunting. 

And I know, you know, Congress and the administration is working very hard, as is the world, on that first 1,000 days, making 

sure that from conception to about the second year, children get the 

right kind of nutritional aid. 

But how do you see tropical diseases as contributing to the stunting problem that we have seen all around the world, particularly 

in places like Africa and North Korea? 

44

Dr. Hall? 

Dr. HALL. Well, thank you. That is a very interesting question 

but a rather complex one. 

I think the answer is that these tropical infectious diseases in 

many cases contribute to malnutrition in a variety of different 

ways. And, obviously, relieving or treating the infectious diseases 

or preventing them in the first place would be a great way to try 

to avoid this problem altogether. And that is really one of the 

things that we would want to focus on with the development of new 

interventions and other approaches to try to minimize the impact 

of these diseases. 

Dr. GOODMAN. Dr. Hotez could probably shed even more light on 

it, but we know simple things like, you know, even improving anemia, which is common in young children who have parasites, can 

improve their performance in school and their learning. 

There is both very obvious malnutrition and infection that occurs, but there are also much more subtle effects, you know, where, 

if these were our children, we would be deeply, deeply concerned, 

and we should be concerned more generally. 

Mr. SMITH. You cite, Dr. Hall, in your testimony that the U.S. 

is the largest public funder of neglected tropical disease research. 

Who would be second? Third? 

And what are we doing to try to—I mean, you mentioned, Dr. 

Goodman, you know, the importance of global collaboration. I will, 

for example, be in Istanbul on Saturday working as co-chairman of 

the Helsinki Commission with 300 parliamentarians from 57 countries. And while we usually work on issues related to human rights 

and democracy, rule of law, I have brought the autism issue there, 

have brought some other issues, you know, where we need to be 

working across—well, that is lawmakers; you obviously work with 

the experts. 

Who are your best collaborators? And how can we be helpful, 

Members in the House and Senate, in promoting that? 

Dr. HALL. So, again, it is very important, because of the multidimensional nature of this problem, to engage multiple stakeholders. 

With respect to the actual rank ordering of who is first, second, 

and third, I would have to get back to you. I can tell you that, certainly, the U.S. Government is the largest funder for neglected 

tropical diseases. Certainly, other foundations, such as the Gates 

Foundation, have had a major role to play. And, certainly, USAID 

and other groups have also contributed in this area, as well as 

overseas agencies. 

Mr. SMITH. It would be helpful if you could get back to us with 

that. 

Dr. Zwane from Evidence Action points out that there are some 

400 million children at risk, schoolchildren, without treatment for 

intestinal worms. How has that improved over the last—I mean, 

how do we reach those? I know the Carter Center works on, you 

know, certain parasites. Are we doing enough to rid the world of 

parasites and especially intestinal worms? 

Dr. GOODMAN. Well, you know, I think they have, from reading 

the testimony, some very innovative programs and are delivering 

medicine and hopefully having a real impact on that. 

45

You know, I think one of the things we are seeing increasingly 

in making a difference in global public health is also integrating 

these different efforts across multiple diseases. You know, it really 

becomes about people getting the care they need. I know WHO and 

others and Gates are really focusing on, you know, how do we deliver these interventions, of course, and how do you keep people 

from getting reinfected with some of these pathogens. So I think 

you need a holistic approach, but, as some of these efforts point 

out, you can make a tremendous amount of difference often with 

inexpensive medicines and interventions. 

Mr. SMITH. Let me just ask a few final questions. 

Are there gaps with USAID funding, funding that Congress has 

provided? You know, I know that OMB goes through everything, 

goes through your agencies to scrub and make final recommendations. But if you had a wish list, how much more do you think 

would need to be added in order to really even push the envelope 

even further? 

And I would say parenthetically, 20 years ago I contacted WHO 

and asked their tropical disease side, what would it take, and actually got an amendment passed that tried to get us on a glide slope 

to meeting some of those figures. 

What would it take? I mean, you know, we can work in a bipartisan way. I believe Dr. Bera and I have talked, you know, previously about filling in those gaps. How do we do it? 

Dr. GOODMAN. Well, you know, I think for USAID and some——

Mr. SMITH. That is not to take anything away from the great 

work you are doing. Please don’t——

Dr. GOODMAN. Right, right. 

Mr. SMITH. I underscore that with exclamation points. It is a 

resourcing problem. 

Dr. GOODMAN. You know, I was going to say, I think for the 

agencies, you know, delivering some of these medicines and care, 

they would be the best to answer, you know, how they feel they are 

doing. You know, I know the whole Federal budget is tight, and we 

all have a lot of obligations and responsibilities. 

From the FDA point of view, there are certainly areas that, were 

there resources available, we could potentially build out. You know, 

those would include enriching our continuing collaborations with 

regulatory agencies around the world. It is sort of like, if you help 

people do something, then they can take that on themselves. 

I think also in this applied science space, where we could develop 

better ways to develop and test these drugs more efficiently and 

work very interactively with industry, you know, those are things 

that are, to some extent, resource-dependent. 

I will say we feel this is very important. And a lot of our staff 

work on these issues, you know, because it means a lot to them, 

even if they may not quite have the bandwidth. 

Dr. HALL. So, again, this is a very important issue. And I think 

that having hearings like this that highlight this issue are important, because it is really crucial to try to engage multiple stakeholders because the solution is not going to come necessarily from 

one group or one agency. It is going to be a very collaborative process, working with a wide variety of groups. And there are many different aspects to this problem. 

46

So it is very difficult to say in a short statement what would be 

required. I think that this is something that would require the engagement of many groups, and it would require a considerable 

amount of thought. 

Mr. SMITH. If you could give it some thought. 

Again, I will give you the example of the way we do business. 

When I was chairman of the Veterans’ Affairs Committee, I became 

very, very aware that homeless veterans were not getting the kind 

of help they need, and it was a resourcing problem. I met with the 

VSOs, they gave some great ideas—American Legion, all the others. 

But I sat down with the people at the VA who really do the 

homeless veterans programs, and I said, what works? Tell us what 

we can do. And I wrote a major landmark law called the Homeless 

Veterans Assistance Act of 2001, which, while it hasn’t solved the 

problem, it has certainly made a major dent in it. 

We would love to be helpful, you know, on this subcommittee if 

we just had a better roadmap as to how to proceed. So consider this 

an engraved invitation. I can’t guarantee success, but we can build 

on your already very considerable success. 

Dr. GOODMAN. I am sure, you know, we would be eager to work 

with you or comment on any ideas that you develop. You know, 

there are some roadmaps out there that may be of interest to you, 

like the Global Vaccine Action Plan we discussed in that area. 

Mr. SMITH. Thank you. 

One last question. You know, you mentioned new tools and incentives, and I think that is what we want to build on, as well. 

You know, we have been admonished by the experts for some 

time now, you, of how important it is not to overuse antibiotic 

treatment, how resistance is growing. We have had hearings in our 

subcommittee on the tuberculosis extreme as well as multidrug-resistant. 

Is there anything you might say about probiotic use and the lack 

of probiotics in people’s gut, where the immunity is so important? 

Are we emphasizing that enough? 

Dr. GOODMAN. Well, there has been incredibly exciting science in 

the last 5 years, I would say, particularly, as we have been able 

to now just take the contents of any environment or any part of the 

human and we find this entire world of microbes there. So we have 

realized that we are not at war with microbes. Some of the ones 

you discuss, you know, clearly they infect a person, it is a bad situation. But much of our health seems to depend on a normal balance of microbes. 

For example, recently this has affected treatment of an antibiotic-associated diarrhea called clostridium difficile, which is a 

complication of antibiotic treatment. And it turns out that restoring 

the normal bacteria to the intestines can help in the majority of 

cases of severe disease. 

So what we are learning is, many things humans do, including 

antibiotic treatment, which may have a very good purpose, may 

have other effects that are more complex. And so we are just getting the tools to study this. I think it is an area that we are going 

to find, as we understand better how to restore or nurture our norVerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL
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mal microbiome, we may find innovations that really help in treatment of disease. 

I think a lot of the reports and, to some degree, you know, products that are out there are not as well-substantiated yet, so we 

don’t know yet what the role is. But I would be surprised if in some 

diseases, just like antibiotic-associated diarrhea, there isn’t going 

to be a really important role for that. 

Dr. HALL. Yes. And I would just add to what Dr. Goodman said, 

that we do have this large program at the NIH, the Human 

Microbiome Project, that is providing incredible insights into how 

the microbiome works and that, as we move forward with this, this 

will hopefully open up many new opportunities to not only better 

understand what is going on but to develop novel interventions 

that would allow us to better intervene in a number of these diseases and in some cases to do things—for example, convert vaccines that are delivered intramuscularly to perhaps an oral formulation, things like that—as we understand better how to capitalize 

on this new understanding. 

Mr. SMITH. Thank you so much. 

Mr. Weber? 

Mr. WEBER. Thank you, Mr. Chairman. You actually asked one 

of the questions I was going to ask. 

I think it is interesting—I will kind of back into my questioning, 

if I may. Dr. Goodman, you said the last 5 years we have discovered an entire world of microbes, I think you said. I guess it is kind 

of like what science fiction used to say, we are not alone in this 

world, and you all are discovering that. 

You made a couple of statements early on, Dr. Hall. You said—

or let me ask you a question from your testimony, actually. You 

talked about the rise of diseases. Is there any way to track or do 

we have guesstimates of how much of that disease is coming into 

our country through the immigration road? Is there any thought or 

discussion given to that? 

Dr. HALL. That is something that I don’t really feel I could comment on. It is really something that perhaps the CDC would be in 

a better position to comment on. 

Mr. WEBER. Okay. Are you aware, do they track that in any 

form, do you know? 

Dr. HALL. They do track—I don’t know the extent to which they 

track this in particular. But they do have an interest in a variety 

of diseases, and they are tracking a variety of different ones. 

Mr. WEBER. Okay. 

Do you have knowledge of that, Dr. Goodman? 

Dr. GOODMAN. For certain diseases, you know, which don’t normally occur here, there is very good reporting—you know, for example, malaria. Typically, it is acquired in another country, and 

then a traveller comes here not knowing he has it and develops illness. For other diseases, you know, there is a focus on the health 

of people who may have moved here. And, certainly, when people 

come from other countries, they may have some of these infections. 

Also, as Dr. Hotez may tell you, many of these infections can be 

acquired here, as I mentioned, even with dengue now. It is not 

really communicable from person to person, but now there are mosVerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL
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quitos in our southern climates carrying these diseases so that the 

diseases are coming to us, not even necessarily through people. 

Mr. WEBER. Okay. And you mentioned that the dengue and the 

Chagas disease, I think is what you call it—I am a blood donor. I 

try to be. Like the Congress, I can’t do it every 8 weeks for some 

reason. But I have AB-blood, which less than 1⁄2 of 1 percent of the 

American population has. Now you know what is wrong with me. 

Dr. GOODMAN. That is what is right. 

Mr. WEBER. You made the comment that dengue and Chagas disease is spreading to blood safety? 

Dr. GOODMAN. Well, there is a potential. You know, actually, 

there has been very little documented spread for Chagas——

Mr. WEBER. Okay. 

Dr. GOODMAN [continuing]. And virtually none for dengue. But 

we are aware that people—dengue, in certain ways, is like West 

Nile virus was, and so we want to be prepared. You know, so there 

may be a period where the virus is in the blood and could be transmitted, so we want to be prepared if that becomes a problem. 

With respect to Chagas disease, people can be infected for years 

without being aware of it, and that is the reason for that concern. 

But right now I don’t think there is an active problem with the 

blood supply. 

Mr. WEBER. Well, I get asked that that question every time I 

give blood, you know, have I ever been diagnosed with this and——

Dr. GOODMAN. That is why. So it is really in this stage of trying 

to be vigilant, do surveillance, and prevent there from being problems, develop tests in case they are needed. 

Mr. WEBER. Okay. And then you also said the Orphan Drug 

Act—and, as a new Member of Congress, I am not really familiar 

with that—you said that neglected diseases almost always qualify. 

Elaborate on that. 

Dr. GOODMAN. Well, the major cutoff point for the Orphan Drug 

Act, as I understand it, is that, to be eligible, a disease has to affect 

less than 200,000 people in the United States. 

So when you think about things like Chagas disease or, certainly, 

rabies or many of the things on that list, while they may be extremely common if you were in Asia or Africa, they are rare here. 

So a sponsor developing a drug for one of those neglected diseases 

would usually be able to take advantage of the benefits of the 

Organ Drug Act, which include, you know, grants for research, as 

I mentioned, additional exclusivity, which can be financially rewarding to companies. 

Mr. WEBER. Right. And so if it is less than, say, 200,000—that 

was one of the questions I had. 

How often—you track the number of infections to the best of our 

ability. 

Dr. GOODMAN. Yeah. 

Mr. WEBER. How often are those numbers updated? Is it every 

month? Every 6 months? Every quarter? 

Dr. GOODMAN. It is a question that depends, to some degree, on 

the resources available to track them and how they are viewed in 

terms of as a public health threat in the United States. CDC has 

overall responsibility for that, and, you know, I am sure we could 

ask them to get back to you with some of that information. 

49

But our country does have probably one of the strongest infectious disease surveillance systems in the world, and it really helps 

us know. But there is a balance between requiring reporting and 

not being too burdensome. So, for some diseases, we probably have 

extremely good idea of numbers, like tuberculosis. For others, we 

may have less certainty, particularly if they often have no symptoms, like Chagas disease, for example. 

Mr. WEBER. Let’s take that question and let’s extrapolate it overseas to follow up on kind of what the chairman was saying, who 

is number two, who is number three. The United States has a 

great track record, and you mentioned the Gates Foundation helping, and you mentioned some others, USAID I think. 

But when we are tracking in other countries and we see an outbreak, how often are those numbers updated? 

Dr. GOODMAN. Well, I think a very positive thing that, you know, 

I have seen even in my time in the government and in the last 10 

years as we faced various influenza threats, for example, is the 

world has become much more aware of the importance of surveillance of infectious disease, there is much more international collaboration——

Mr. WEBER. Okay. Is there an FDA counterpart in China or 

Japan or Russia? 

Dr. GOODMAN. Well, in this case, it would be more, you know, the 

CDC counterpart for disease surveillance. But, yes, there are in 

many of these countries. And——

Mr. WEBER. They communicate back and forth? 

Dr. GOODMAN. Yeah. In many cases, there are scientific exchanges between our governments and theirs. There is also something called the Global Health Security Initiative, which involves 

some of the U.S.’s major allies, that shares information on these 

diseases. 

So there is much, much more than there used to be. But there 

also is a concern, as you can imagine, in many countries of the 

world that are very resource-poor; they may not have either the resources or, in many cases, the expertise to devote to disease surveillance. So there is a lot of recognition of the importance of trying 

to, wherever we can, improve surveillance in those areas too. 

Mr. WEBER. And that was one of my questions. Would you agree 

that developing countries that maybe don’t have an infrastructure, 

maybe not as much clean water, maybe not as good health care, 

that part of helping to stabilize them, if you will, in some fashion, 

is going to be training and equipping them even at that basic level? 

Dr. GOODMAN. Absolutely. Absolutely. You know, knowing what 

is going on—even in the United States, if you think about health 

of our communities, if you don’t understand fully and you don’t 

have good data about the diseases people have, you know, how do 

you track changes, how do you make people healthier? 

So that disease surveillance is very important all over the world, 

and the same with the other kinds of expertise. You know, there 

are many countries throughout the world that have made tremendous progress, and there are a lot of exciting models for how to improve things in those areas. 

Mr. WEBER. Well, I am just wondering how much of our focus—

it is kind of like the old saying, you give a man a fish, you feed 

50

him for a day, you teach him to fish—we can give them vaccines, 

but can we help with their infrastructure and their training so that 

the underlying—I won’t say problem—the underlying situations 

that keeps them from being maybe as healthy and as knowledgeable as they could—might help. 

Let me shift gears for just a minute. You made the comment you 

are trying to build regulatory capacity around the world and you 

are trying to get, I think, access to the products sooner. What is 

that time frame, when a product is begun and studied and put out? 

Is that typically 3 months? Three years? 

Dr. GOODMAN. You mean for other countries? 

Mr. WEBER. Well, for us to get a product—well, your comment 

was you were trying to build regulatory capacity around the world 

and get access to the products sooner. 

Dr. GOODMAN. Well, so what I am thinking about, for example, 

is, what if there is a lifesaving intervention that could help people, 

you know, who are primarily in other places? You know, there are 

many factors in having access to that. There is cost; there is their 

ability to deliver it. 

But one of them also is that, you know, really, FDA or the European medicines agencies, you know, which are relatively wellresourced and experienced, you know, in reviewing products, we 

don’t approve products for use in other countries, rightly so. You 

know, countries have their autonomy and need to be sure that 

their assessment of a product for use in their country is sciencebased and satisfies their needs. 

So one of the things we have tried to do through WHO is support 

both countries and regions who are trying to develop that regulatory capacity. 

Mr. WEBER. Do you find generally that most of those countries—

how do you say it—they rely on us, rely on the FDA’s assessment? 

Or do they pretty much want to do their own testing? 

Dr. GOODMAN. You know, as you can imagine, there is incredible 

diversity. A lot of countries look to FDA and also to our European 

colleagues, you know, as having expertise and really may not rely 

on but use our reviews as part of the basis for their decisions. 

But many of them are coming together also in regions, for example, in Africa and in the pan-American region, to build their own 

regulatory capacity and to cooperate with us, you know, almost as 

partners and equals. We have had situations where we can learn 

from work they are doing—for example, in Latin America, the monitoring of the 2009 influenza outbreak. Studies of vaccine safety for 

other vaccines have been performed there. 

So it is really a win-win solution when we build that capacity. 

You know, of course, people have to want that and invite us, and 

we have to provide it in a way that is useful to them, which may 

be different than what we do. 

Mr. WEBER. Right. 

Okay. That is all my questions. Thank you, Mr. Chairman. 

Mr. SMITH. Thank you very much. 

Just one final question. And, again, thank you for your patience. 

Dr. Peter Hotez, as you know, the president of the Sabin Vaccine 

Institute, in his testimony will say that NTDs are the most imporVerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL
51

tant diseases you have never heard of. He talks about how well 

over 1 billion people suffer from it. 

But he has a very important part in his testimony where he talks 

about a problem that is coming to light with regards to female genital schistosomiasis that malaffects some 100 million girls and 

women in sub-Saharan Africa, and makes a point that one thing 

very concretely that we might do—you might do, we might do collectively—is to establish a center of excellence for NTDs, that the 

time has come for such a center. 

Again, I would note parenthetically, back in 1998, I am the author of the Combating Autism Act. It took me 3 years to get it 

passed. We put it as Title I of the Children’s Health Act in 2000. 

And then, just most recently, I was the author of the reauthorization for 3 years. 

And there was pushback initially from some within the agencies 

about a center of excellence for NIH and for CDC. I noted at the 

time that we were spending $287,000 per year straight line for 5 

years at CDC on autism, even though there was a huge seeming 

epidemic, developmental epidemic, arising. 

And I am wondering if perhaps it might be time for a center of 

excellence for NTDs. What are your thought? 

Dr. Hall? 

Dr. HALL. Well, again, I think that product development is a very 

complex area. It requires a multidisciplinary approach. And it is 

really important to bring together groups that have a variety of different expertise. And that is one of the things that really makes 

for successful product development. 

At the NIH, we have tried a variety of different methods, and 

what we have found works is that you have to have a spectrum of 

activities that run from basic research through to preclinical target 

validation, preclinical research, translational research, and then on 

to clinical and field evaluation, and that when these parts are 

working together well, then you really are able to accelerate the development of products. 

Our current mechanisms are actually quite flexible, responsive, 

and timely. And just to give you an example, about a third of the 

global antimalarial drug pipeline came out of NIH-supported research and has been handed off to partners. We have supported 

multiple products for NTDs, including vaccines, drugs, and 

diagnostics. And we worked with a wide variety of different technologies, different companies, and different entities to try to accelerate that. 

And just to build on this question about screening donated blood 

that came up earlier, in fact there are at least two blood tests for 

screening the blood bank, the blood supply, and at least one of 

those came out of NIAID-supported research. 

So our feeling is that a strong multidisciplinary approach with a 

variety of mechanisms and technologies is really very helpful in 

terms of bringing these things forward. 

Mr. SMITH. Thank you. I do have a lot of questions but, in the 

interest of time, will submit them. 

Thank you for your tremendous leadership, and we look forward 

to working with you. 

Dr. HALL. Thank you. 

52

Dr. GOODMAN. Thank you very much. 

Mr. SMITH. Now we would like to invite our second panel to the 

witness table, beginning with Dr. Peter Hotez, who is the president 

of the Sabin Vaccine Institute and leads the Texas Children’s Hospital Center for Vaccine Development based at the Baylor College 

of Medicine in Houston, Texas. He is also the founding dean of the 

new National School of Tropical Medicine at Baylor College of Medicine. 

His academic research focuses on vaccine development for a wide 

range of neglected tropical diseases around the globe as well as 

studies to increase awareness about the neglected tropical diseases 

in developing countries and in the United States. Dr. Hotez created 

the Sabin Vaccine Institute Product Development Partnership and 

was instrumental in creating the Global Network for Neglected 

Tropical Diseases. 

We will then hear from Dr. Jay Siegel, who is the chief biotechnology officer and head of scientific policy at Johnson & Johnson. He is actively engaged in R&D leadership and in policy development at the national as well as international levels with regard 

to regulatory and scientific issues. 

Dr. Siegel joined J&J in 2003, and prior to that he worked at the 

FDA’s Center for Biologics Evaluation and Research, where he 

worked to regulate the biotechnology industry. He has authored 

numerous publications in the area of clinical trials, design, biotechnology, immunology, and drug development policy. 

J&J submitted written testimony on April 20th at one of our 

hearings back on drug-resistant disease, and we are very grateful 

for that but also even more to have you here today. 

We will then hear from Dr. Alix Zwane, who is executive director 

of Evidence Action, a new organization working to scale proven 

interventions to improve the lives of the poor in Africa and Asia, 

and the Deworm the World Initiative, which supports the scaleup 

of school-based deworming programs worldwide to improve children’s health, education, and long-term development. 

She previously worked for the Bill and Melinda Gates Foundation, where she led the Water, Sanitation, and Hygiene Initiative 

strategic planning process and their measurement and evaluation 

plan. Dr. Zwane worked at Google.org to develop and manage 

health and water issues, as well. 

Dr. Hotez? 

STATEMENT OF PETER J. HOTEZ, M.D., PH.D., PRESIDENT, 

SABIN VACCINE INSTITUTE 

Dr. HOTEZ. Thank you very much, Chairman Smith. I appreciate 

the opportunity. Congressman Weber, thank you so much. It is a 

pleasure to come before you today to discuss the importance of U.S. 

Investments in neglected tropical diseases. But what I also want to 

do today is make you aware of a very troubling and disturbing 

problem of neglected tropical diseases in Texas and in the southern 

United States that we have not been aggressively addressing. 

A copy of my written testimony has been submitted for the 

record. 

As you pointed out, I serve as president of the Sabin Vaccine Institute, which has just celebrated its 20th anniversary, and also 

53

founding dean of the new National School of Tropical Medicine at 

Baylor College of Medicine in Houston which was launched in 

2011. I am a pediatrician and a scientist who has devoted my entire life to developing innovations to combat neglected tropical diseases (NTDs) including new vaccines and drug packages. 

You are absolutely right; these are the most important diseases 

you have never heard of. Today, virtually every person on our planet who lives in extreme poverty, lives below the World Bank poverty figure of $1.25 a day, the bottom billion, as they are sometimes 

called, and suffers from one or more of those neglected tropical diseases. 

A couple of people brought up the problem of intestinal worms, 

such as hookworms, which feed on blood and actually rob children 

of nutrients. The problem with stunting is that instead of feeding 

the kid, you are feeding the worms. These are the leading causes 

of growth stunting on our planet. 

What is even worse is intestinal worms like hookworms have 

been shown to reduce childhood intelligence and cognition. And 

now the economists have come in from the University of Chicago 

to show that chronic hookworm infection can reduce future wage 

earning by 40 percent. 

So this is why these diseases are so devastating: Not necessarily 

because they are killers; they are trapping people in poverty. They 

actually thwart future wage earnings. So getting rid of hookworms, 

it turns out, may be one of the most cost-effective ways to lift the 

bottom billion out of poverty. 

And it is not just children. More than a quarter of pregnant 

women in sub-Saharan Africa have hookworms and go into labor 

and delivery with profound anemia and risk for severe morbidity 

or even death. As my obstetrician colleagues point out, it is not 

that African women bleed more during childbirth, but it is that 

they begin the delivery process with two strikes against them because they start out with so little blood because they have 

hookworms. These are not rare diseases. One-quarter to one-third 

of pregnant African women have this condition. 

But an even more or equally concerning problem that I also want 

to tell you about in Africa today before I move to the U.S. is what 

is coming to light is a manifestation of snail fever known as female 

genital schistosomiasis, a parasitic infection that produces bleeding 

ulcers on the cervix, the uterus, the lower genital tract. It causes 

bleeding, pain, terrible shame, terrible stigma. 

This is not a rare disease—it impacts 100 million girls and 

women and this may be the most common gynecologic condition of 

girls and women on the African continent. Now, can you imagine 

if we had 100 million girls and women in the U.S. With female genital schistosomiasis? As a society, we would never tolerate it. But 

because it affects girls and women who live in abject poverty, most 

often in remote parts of rural Africa, they go untreated. 

Now, what is very equally concerning is the fact that this female 

genital schistosomiasis is associated with a three- to four-fold increase in horizontal transmission of HIV/AIDS. It may be Africa’s 

most important co-factor in the AIDS epidemic, and you have never 

heard of it. So we need to change that. 

54

Just a couple of other final examples to wrap up the global situation is the stigmatizing effects of cutaneous leishmaniasis, also 

known as Aleppo ulcer or Aleppo evil. It is now affecting more than 

100,000 people living in Syria who have fled to refugee camps. It 

has also been a problem among our U.S. troops in Iraq and Afghanistan. But in the Middle East, again, it is girls and women who are 

permanently scarred and rendered unmarriageable or not allowed 

to hold their children as a result of this neglected tropical disease. 

And the point I keep wanting to emphasize is the magnitude. Everything I say is multiplied times 100,000 or, in some cases, 100 

million—it is just an enormous amount of suffering. 

So every year we are learning about these new tragedies from 

neglected tropical diseases, many of which are counterintuitive. 

Our recent study found that these diseases, for instance, hit Catholic-majority countries particularly hard, such as Chagas disease in 

Honduras or hookworm and schistosomiasis in Angola and the 

Philippines. It is no accident. 

You know, these diseases are—you all know about emerging infections. This is what gets the newspapers’ attention, right? Avian 

flu or H7N9. These diseases are just the opposite. These have been 

around forever. These have plagued humankind for centuries. I like 

to call them the biblical diseases, because you can find detailed descriptions of these diseases in the Bible, and also in the Talmud, 

the Vedas, the writings of Hippocrates, and Egyptian papyri. That 

is how long they have been around. 

Now, the good news—and there is some good news to this story—

is that we can do something about seven of the most common neglected tropical diseases for a ridiculously low cost, approximately 

50 cents per person per year. 

So what happened was, in 2005 and 2006, with colleagues from 

the United Kingdom, we put forward this concept of a rapid impact 

package in 2006, which is now being scaled up through the support 

of the United States Agency for International Development, 

USAID, and with advocacy from our Global Network for Neglected 

Tropical Diseases, which is a Sabin initiative. And thanks to generous drug donations from leading pharmaceutical companies like 

Johnson & Johnson, a unique and innovative public-private partnership has been created to efficiently and cost-effectively address 

neglected tropical disease control. 

And the cost is, again, ridiculously modest, partly because we are 

leveraging more than $4 billion worth of drugs that have been donated from the pharmaceutical industry. And more than 250 million people have been treated. This may be one of the world’s largest public health interventions. 

So, I don’t want to leave today without saying that it is extremely important that you continue support for USAID’s Neglected Tropical Disease Program. It is very low-cost. It is important that we at least match 2013 levels to deliver these medicines 

to people who need them the most so they can benefit from these 

treatments. 

While these diseases are incredibly potent, the U.S. Government 

has actually been the lead in supporting these neglected tropical 

disease packages; the U.K. has now also provided support. We also 

think the private sector needs to step up, as well as some of the 

55

other G–20 countries. We established the Global Network for Neglected Tropical Diseases and our END7 campaign to raise awareness about these diseases. 

And, if I may, I would like to show a 1-minute video about these 

conditions. 

[Video shown.] 

Dr. HOTEZ. This is lymphatic filariasis, or elephantiasis. That is 

120 million people with lymphatic filariasis, 800 million with 

roundworm, 700 million people with hookworm. Notice the numbers add up to more than 1 billion. People are polyparasitized. 

They have multiple diseases at the same time. 

Now, given the recently revealed links between snail fever and 

female genital schistosomiasis and AIDS, as well as malaria and 

hookworm. You’ve asked, where do we go from here? Well, I think 

version 2.0 includes looking at better links between the USAID Neglected Tropical Disease Program and other U.S. global health investments, such as PEPFAR or the Global Fund. So, for instance, 

PEPFAR doesn’t actively have a program to link it up with female 

genital schistosomiasis, even though it may be the most important 

co-factor in the AIDS epidemic. So we need to do a better job linking. 

But all of them are extraordinary programs. The Global Fund to 

Fight AIDS, TB, and Malaria needs to do the same thing. And the 

few times they have done it, the results have been extraordinary. 

Because Global Fund supported lymphatic filariasis, one of those 

diseases in Togo, it has now been eliminated in Togo. So there is 

incredible power that could be brought to bear by bringing 

PEPFAR and the Global Fund into the equation. 

We also need to encourage governments beyond the U.S. I think 

it is unfair that we put all of the burden on U.S. taxpayers. Our 

country has been more generous than any other, but we need to 

bring in some of the other G–20 countries. What is Indonesia doing 

about this? What is India doing about this? What is China doing 

about this? China is investing billions of dollars in sub-Saharan Africa, and, so far, not a penny is going to neglected tropical diseases. 

So action item number two is we have an exciting new Office of 

Global Health Diplomacy in the State Department. What is going 

to be the role for them? Well, I think one of them would be putting 

diplomatic pressure on all the G–20 countries to step up support 

for NTD control and elimination. 

So we are finding a lot of these NTDs among G–20 countries. 

One of the surprising findings that we have made in the last 2 

years is that, while we think of these diseases exclusively as subSaharan African diseases, in fact, the lion’s share of most neglected 

tropical diseases are in the G–20 countries, the 20 wealthiest 

economies. It is the extreme poor living in the wealthiest economies. 

And that includes the United States. We have 20 million people 

now in the U.S. that live in what is called extreme poverty; that 

is a standard deviation below the poverty line. It also includes 

now—and this is an amazing fact—1.46 million families, with nearly 3 million children, who live on less than $2 a day. So, for the 

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mark for global poverty and applying it to the United States, especially in the southern United States. 

At our National School of Tropical Medicine based in Houston, 

what we have done now is to take that global health lens and turn 

it inward. Beginning in 2008, I identified a group of neglected tropical diseases in the U.S., mostly in the southern U.S. and particularly in Texas, that is affecting 5 million Americans. 

So 5 million Americans have one or more neglected tropical diseases. It includes 2.8 million African-Americans with toxocariasis, 

a larval worm infection of the lungs and the brain that has been 

now linked to pulmonary dysfunction and asthma, developmental 

delays, and seizures; millions of African-American women with 

trichomoniasis that has been linked with HIV/AIDS; hundreds of 

thousand of Hispanics with Chagas disease, a debilitating heart 

condition. 

To get to your question, Congressman, we have found now in 

Texas that 1 in 3,500 blood donors are seropositive for trypanosoma 

cruzi, or have Chagas disease. 

Now, for the most part, extremely poor people and people who 

live under extreme conditions don’t give blood. So this is an extreme underestimate of the number of true cases of Chagas disease. Some estimates say 200,000 people with Chagas disease are 

in the State of Texas. That is probably a little high. We are finding 

it now possibly among the homeless in Houston. We are finding it 

widespread. 

Another key point to mention is, one, they are not rare diseases; 

two, everyone thinks this is a problem of immigration. Immigration 

may be a part of it, but we believe there is actual transmission of 

these diseases going on in the U.S. 

The link is poverty. There is something about people living in extreme poverty, whether it is in the Third or Fifth Ward of Houston, 

whether it is in south Texas. This is what seems to be predisposing 

it. 

We have a dengue problem in Texas. We know it is widespread 

in south Texas. We believe now that it might have emerged in 

Houston, as well. We have had the Aedes aegypti mosquito here for 

a long time. It is occurring primarily in the poorest parts of Houston. 

Why the link to poverty? Why is dengue linked to poverty? We 

don’t really know. You know, when you drive through some of these 

areas, you see people without window screens, without air conditioning, or they will have those box-like air conditioners that are 

very porous. Maybe that has something to do with it. 

Our scientists at the National School of Tropical Medicine have 

identified a new syndrome linked with West Nile virus. Everyone 

knows about the very rare condition of neurologic involvement. We 

are finding maybe 10, 20 percent of people with West Nile are getting chronic renal disease, something that we didn’t know about before. 

So this is a problem that we really need to take on. What do we 

do about it? We are not doing programs of active surveillance looking for these diseases. These problems are being largely ignored. 

We are not really doing anything to investigate how these diseases 

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funded, they haven’t had the resources to really take this on. So 

we are trying to fill in the gaps and are doing this at the National 

School of Tropical Medicine. 

And, this gets to this whole idea of creating a ‘‘Center of Excellence.’’ I think the Center of Excellence concept has to take on neglected tropical diseases abroad among the bottom billion, taking 

on the biblical diseases, but we also need to have that ‘‘Center of 

Excellence,’’ address the at least 5 million Americans living in extreme poverty in the United States with these NTDs. 

A fair amount of effort is going to be needed for research and development. That is one of the things that we are doing at our Sabin 

Vaccine Institute, which is a nonprofit product development partnership, a PDP, that will make the products that the drug companies can’t make or won’t make. Not that the drug companies are 

bad guys. They have been amazing, incredibly generous in donating 

medicines. But it is another leap of faith to ask them to go back 

to their shareholders and ask them to invest tens of millions of dollars for R&D. 

That is what we are doing at Sabin Vaccine Institute and our 

National School of Tropical Medicine. We have a low-cost 

hookworm vaccine that is in phase one trials; a schistosomiasis 

vaccine that is moving into phase one trials through support from 

Dr. Lee Hall, through the National Institute of Allergy and Infectious Diseases. 

And now we are developing new vaccines for Chagas disease and 

leishmaniasis through support from the Carlos Slim Health Institute and a man named Len Benckenstein, through the Southwest 

Electric Energy Medical Research Institute. So we are very excited 

about being able to advance these products into clinical development. 

So we do urge you to vigorously support private-public partnerships, product development partnerships, that will develop not only 

the developing world but will ultimately lift people out of poverty. 

Mr. Chairman, Congressman Weber, Congressman Stockman, 

this concludes my testimony. Again, I thank you for your interest 

in furthering U.S. engagement in neglected diseases and the opportunity to address you this afternoon. And, of course, I am always 

happy to answer questions. Thank you. 

[The prepared statement of Dr. Hotez follows:]

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Mr. SMITH. We have been joined by Congressman Stockman. 

Mr. STOCKMAN. I have a question for Dr. Hotez. 

Congress Weber and myself are both in the area in which they 

spray for dengue fever. And I know in our neighborhood in the evenings as the sun is setting they are spraying. I think it is for dengue fever. 

Dr. HOTEZ. Actually, you are spraying more for culex mosquitos 

that transmit West Nile virus. So the spraying could be extended 

to daytime spraying to get the Aedes aegypti mosquitos, as well. 

Mr. STOCKMAN. So those are the ones that carry the dengue, the 

daytime mosquitos? 

Dr. HOTEZ. That is right. 

Mr. STOCKMAN. I understand, too, it is mostly the female mosquitos, right? 

Dr. HOTEZ. Yeah. 

Mr. STOCKMAN. Do you know Edward Rensimer? He is a travel 

doctor in Houston. Do you know him too? 

Dr. HOTEZ. I don’t. 

At our National School of Tropical Medicine now, we have actually created what we think is the first tropical medicine clinic in 

the United States at Baylor College of Medicine with Ben Taub 

General Hospital—it is a partnership—where we now see patients 

with all of these diseases coming in every Friday. 

Mr. STOCKMAN. So you are at the medical center? 

Dr. HOTEZ. I am at the medical center, right, Baylor College of 

Medicine at the Texas Medical Center. 

Mr. STOCKMAN. Yeah. 

Dr. HOTEZ. So it is amazing, every Friday we have patients coming in with Chagas disease, with cysticercosis, a brain parasitic infection. And we are seeing amazing stories of cutaneous leishmaniasis coming in. So it is pretty impressive. 

Mr. STOCKMAN. But there was a prominent scholar—and correct 

me if I am wrong, but is some of this or a lot of it, can it be delegated or attributed to immigration? 

Dr. HOTEZ. So, I am not sure when you walked in. I think immigration may be a part of it, but I don’t think it is a major part of 

it. 

My point is it is linked with poverty, so that we have transmission of these diseases right now going on within the borders of 

Texas, more south Texas, in Houston. It is also along the Gulf 

Coast. It is in Florida. 

There is something about this pernicious combination of extreme 

poverty and warm, moist climate, just like it is elsewhere. I mean, 

after all, Houston is on the 30th parallel, right? 

Mr. STOCKMAN. Yeah. 

Dr. HOTEZ. It is on the same parallel as New Delhi and Cairo 

and——

Mr. STOCKMAN. And in reference to our own city, I think the 

mosquitos bite anybody. I don’t think they just bite poor people. 

Dr. HOTEZ. Yeah, so, as I said, we are trying to get our arms 

around what is it about poverty that seems to make people particularly susceptible. 

Mr. STOCKMAN. I mean, they are pretty smart mosquitos if they 

know the difference. 

69

Dr. HOTEZ. No, I will tell you what it is. Here is what I think 

it is. I think it is, people living in extreme poverty have more exposure because they don’t have the adequate housing, hence they are 

getting exposed more to mosquitos. We are seeing very high rates 

of West Nile virus among the homeless. One of our faculty members has found the same with Chagas disease. 

So I think—and we haven’t proven it; this is only a hypothesis—

that the link between poverty and these diseases is levels of exposure to the vectors. 

Mr. STOCKMAN. I was in DRC, and I was telling the chairman 

about how I experienced firsthand some of the tropical diseases. 

And their inability to deal with it is pretty sad, actually. I think 

the basic stuff they didn’t have in their—in fact, it was supposed 

to be their advanced hospital. I was in Kinshasa, and it was horrible. 

Dr. HOTEZ. Yeah. 

Mr. STOCKMAN. It was absolutely horrible. So I appreciate what 

you are doing and the research you are doing. It is really needed. 

And for someone that got sick, pretty sick there, I very much appreciate what you are doing. 

Dr. HOTEZ. We actually have a paper coming out at the end of 

July on the Democratic Republic of the Congo (DRC), and NTDs. 

And I call them ‘‘Neglected Tropical Diseases in the Heart of Darkness,’’ referring to Joseph Conrad’s book. So you are absolutely 

right, the DRC is a brutal place for these diseases. 

Mr. STOCKMAN. Yeah. And I know some of our people from WHO 

are over there dressed up in the suits, and they thought they were 

ghosts, and they murdered them, which——

Dr. HOTEZ. Oh, my God, that is terrible. 

Mr. STOCKMAN [continuing]. Was not good. They were there for, 

what is it, the bleeding of the pores——

Mr. SMITH. Ebola. 

Dr. HOTEZ. The Ebola virus, right, right. 

Mr. STOCKMAN. So we have to do something to educate them before we put people in that kind of situation. 

Dr. HOTEZ. Yes, we have this epidemic now of healthcare workers getting killed while doing noble pursuits. We see this now in 

the delivery of polio vaccines with healthcare workers in Pakistan——

Mr. STOCKMAN. Yeah, they spread the rumor that it was——

Dr. HOTEZ. Yeah. It is just so profoundly sad, yeah. 

Mr. STOCKMAN. Well, Mr. Chairman, I would just—go ahead. 

Mr. SMITH. Oh, I was going to go to Dr. Siegel. 

Mr. STOCKMAN. Oh, okay. 

Mr. SMITH. Unless you want to——

Mr. STOCKMAN. No, I would just yield back. And thank you. I appreciate it. 

Mr. SMITH. Dr. Siegel, please proceed. 

STATEMENT OF JAY SIEGEL, M.D., CHIEF BIOTECHNOLOGY 

OFFICER AND HEAD OF SCIENTIFIC STRATEGY AND POLICY, 

JOHNSON & JOHNSON 

Dr. SIEGEL. Thank you. 

70

Chairman Smith, members of this esteemed committee, thank 

you for inviting me to testify. My name is Jay Siegel. I am chief 

biotechnology officer and head of scientific strategy and policy at 

Johnson & Johnson. 

On behalf of the Johnson & Johnson family of companies, I applaud you for organizing this hearing on the important subject of 

treatments for neglected diseases. As an infectious disease physician, a retired United States Public Health Service officer, and a 

former senior FDA official, as well as a pharmaceutical R&D executive, I greatly appreciate both the importance and challenge of this 

issue. 

There is a deep and lasting commitment at Johnson & Johnson 

to global public health. In 2012, we extended that commitment as 

we signed the London Declaration on Neglected Tropical Diseases. 

And, earlier this week, we created Johnson Global Public Health, 

an internal organization to coordinate and advance our efforts in 

developing and providing access to therapies with important global 

public health impact. 

Johnson & Johnson has several active efforts in this area. We 

are collaborating on development of a new bioavailable formulation 

of flubendazole with potential to eradicate the parasites that cause 

lymphatic filariasis and onchocerciasis, debilitating diseases affecting millions of people in tropical counties. 

We donate more than 200 million doses of mebendazole yearly 

through the Children Without Worms partnership as part of a comprehensive strategy to reduce the burden of intestinal parasites. 

And we are now developing a chewable formulation of mebendazole 

to enable its use in younger children. 

We discovered and developed Sirturo, the first new medicine for 

tuberculosis, or the first medicine with a new mechanism of action, 

in more than 40 years. Recently approved for use in treatment of 

adults with pulmonary multidrug-resistant tuberculosis, Sirturo 

will help address this important and growing public health challenge. Our 10 years’ investment in Sirturo discovery and development will continue and grow to address product introduction, to ensure appropriate use and access, and to continue clinical research. 

Cost recovery from sales of Sirturo is expected to be relatively 

small, elusive, and incomplete. 

Of course, our investments in these projects are not motivated by 

the potential profits, but rather by the opportunity to make a contribution to global public health. Notwithstanding our efforts and 

the laudable efforts of many other public- and private-sector organizations, as you have been hearing, much, much more remains to 

be done. 

In the U.S., we ought to address these issues with a sense of urgency. Given the realities of climate change and increasing international travel, it may be more prudent for us to conceive of several diseases that occur predominately in developing countries but 

rarely in the U.S. not as orphan diseases but rather as morphing 

diseases—morphing in terms of size and extent of their reach. 

Americans at home are at increasing risk, as you have heard from 

several before me, for example, with regard to dengue fever. 

Even diseases that are more tightly constrained to resource-limited settings often take their toll not only in terms of tremendous 

71

human suffering but also in terms of social and economic impact 

that can reverberate across our increasingly interconnected world. 

We greatly need new and improved therapies, and Congress can 

accelerate progress toward that goal. U.S. Government agencies 

and departments, including FDA, NIH, CDC, and the DoD, play 

important roles in addressing neglected diseases and can be and 

have been valuable partners. 

These efforts and partnerships can be facilitated. A reworking of 

R&D models, regulatory models, incentive models, and partnership 

models could enable greater investments and greater progress. In 

my written testimony, I describe several existing models that might 

stimulate more investment and more progress in this area. 

Drawing on our experiences, we encourage Congress to reflect 

upon three considerations in the design of policies to stimulate investment and accelerate progress in this area. 

First, such policies should take into consideration a holistic view 

of the costs and risks across all stages of developing and supporting 

treatments. 

Second, the menu of options available to stimulate investment 

should be varied and extensive. This approach would help spark 

the level of investment needed, would address all stages of development, and would expedite assessment of which options work best. 

Third, policies should encourage partnerships that bring broad 

expertise to bear and help to diffuse the risk of drug development 

and delivery across multiple actors. 

In conclusion, the challenge of addressing neglected diseases is 

large and complex, but the U.S. Congress has opportunities to facilitate, coordinate, and incentivize the needed efforts of many interested and capable parties, thereby accelerating important advances against these devastating diseases. 

Thank you, Chairman Smith and members of this committee, for 

your leadership on this issue. I look forward to answering any 

questions you may have. 

Mr. SMITH. Dr. Siegel, thank you very much for your testimony 

and for your very concrete recommendations. 

[The prepared statement of Dr. Siegel follows:]

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Mr. SMITH. Dr. Zwane? 

STATEMENT OF ALIX ZWANE, PH.D., EXECUTIVE DIRECTOR, 

EVIDENCE ACTION 

Ms. ZWANE. Thank you. Thank you very much. 

Mr. Chairman and members of the committee, thanks for the opportunity to speak with you today. 

My name is Alix Zwane, and I am the executive director of the 

Deworm the World Initiative. That is a consortium of organizations 

which actively supports the scaleup of national or, in the case of 

India, state-level school-based deworming programs. 

I come to my leadership role in the Deworm the World Initiative 

because my full-time job is the executive director of Evidence Action, a new nongovernment organization working to scale proven 

interventions to improve the lives of the poor in Africa and Asia. 

We are the leaders of the Deworm the World consortium. 

School-based deworming is now recognized as one of the smartest 

and most cost-effective global health investments by leading academic centers, including our partner, Innovations for Poverty Action. This year, Deworm the World has helped our Government 

partners provide deworming treatment to over 35 million children 

in Kenya and in India. 

My testimony today offers some practical recommendations on 

how to bridge the treatment gap in mass drug administration for 

the treatment of soil-transmitted helminths, schistosomiasis, and 

other intestinal parasites. 

I am not going to focus primarily on a plea for a large infusion 

of donor resources. Thanks to generous drug donation programs by 

our pharmaceutical company partners like Johnson & Johnson, the 

quantity of available drugs currently outstrips programmatic demand. Our experience suggests that targeted, catalytic investments 

can be hugely beneficial. 

I also do not focus on calling for additional political will from developing-country governments. We recognize that our partner governments have many competing priorities and limited budgets. 

They have to make hard choices, even with the very best of intentions. 

In this summary of my submitted testimony, I highlight instead 

how the gap between service need and service delivery can be 

bridged by bringing useful but nonintuitive information and evidence to the attention of policymakers; how sharing targeted and 

practical lessons about best practices and implementation can leverage and unlock developing-country government money; and reducing the NTD knowledge gap. I will discuss each of these very 

briefly in turn. 

First, on the question of evidence, as has been discussed earlier 

in this session, the magnitude of the benefits from deworming primary-school-age children is truly striking. A 2007 study that measured the impact of an early 20th-century hookworm eradication effort in the southern United States found treatment to increase 

school enrollment, school attendance, and literacy. A randomized 

control trial in Kenya of a school-based deworming program found 

similar results. 

85

And by tracking those children over time, it has been shown that 

the benefits translate into more hours worked and higher wages for 

adults when they enter the formal labor market. This suggests a 

clear and identifiable link between global health interventions that 

reduce the suffering of children now and economic growth over the 

longer run. 

Sharing these kinds of results with policymakers as part of a 

larger package of services or a structured engagement on doing 

more evidence-based policymaking more generally can help the decision-makers prioritize investments so that their scarce resources 

stretch further. 

Increasing the capacity of governments to implement schoolbased deworming can make a path to sustainable, scalable services 

less daunting and more politically palatable. It is a challenge to 

convince a ministry of health official to take on a new national program, but by demonstrating how this can be done, by showing what 

kind of support can be provided that is targeted and straightforward, it can make it easier to take on a new program. 

The kind of support needed includes mapping which areas of the 

country have the highest level of worm infection, creating plans 

and budgets that actually target those areas carefully, designing 

program processes and materials for training teachers and coordinating implementation logistics, and developing monitoring and 

evaluation systems to reliably assess program performance. 

Joint ownership across ministries of education and health is crucial to school-based deworming. At Deworm the World, we help to 

cultivate that partnership. We also identify opportunities to integrate with other synergistic programs, such as micronutrient initiatives or vitamin A programs that also target schoolchildren. By 

leveraging other programs and piecing together budgets from different pots, we can unlock government resources and point the way 

to success. 

Donor support for technical assistance in school-based 

deworming can be a highly leveraged form of support for child 

health. For example, we estimate that for every dollar of donor resources that we bring to bear for our work in India, we leverage 

something like $17 of Indian Government money. That has helped 

us to treat some 30 million Indian children across several states in 

the past year. 

Finally, reducing the knowledge gap. Thanks to investments by 

USAID and The Gates Foundation and others, we understand increasingly well the benefits of deworming and how to achieve scale 

with quality. However, we continue to face uncertainty about the 

necessary duration of mass treatment. 

As an implementing organization, I can tell you it is difficult to 

work with a government counterpart to bring a new program on 

board when you can’t tell them with certainty if they are making 

a 5-year commitment or a 10-year commitment. Those are very different things from a budget perspective and a political perspective. 

But right now there is a lot of uncertainty just from a science 

perspective about how long to do mass treatments. This uncertainty makes risk-averse officials hesitant to act. Increased effort 

to understand how treatment strategies should change over time 

86

would be enormously beneficial to achieving our collective goals 

around coverage. 

In summary, our experience in the Deworm the World Initiative 

suggests that supporting the activities I have discussed here can 

address the political, technical, and managerial challenges to expanding deworming programs at a cost that is less than 50 cents 

per child per year. This is one of the most cost-effective means of 

improving educational outcomes for children in developing countries that we know, and expanding its reach is well within our 

grasp. 

Thank you for your attention and the opportunity. 

Mr. SMITH. Dr. Zwane, thank you very much for your testimony 

and for your leadership. 

[The prepared statement of Ms. Zwane follows:]

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Mr. SMITH. And I can say, I am practically in awe with the information conveyed to this committee. I have followed this, but, as 

you said, Dr. Hotez, this is the disease that you never heard of, 

most people have not heard of, and yet it is having such a debilitating impact on countries, including our own. 

Dr. Zwane, you mentioned the 1-to-17 ratio in India. Are the occurrences of worms, the prevalence, is it mostly with the Dalits? Is 

it, like Dr. Hotez talked about, disproportionally poor people who 

suffer from it? 

And when you mentioned the Kenya study, that also comports 

with what you were saying, Dr. Hotez, about the hookworms have 

actually been shown to reduce childhood intelligence and cognition 

and earnings by 40 percent or more. If we want to see economic 

growth, people reaching their objectives and maximizing their potential, it seems to me that getting rid of the worms has to be a 

very significant priority for us here and people all over the world. 

Dr. HOTEZ. As they say, it is the worm, stupid. Right? 

Mr. SMITH. You said, Dr. Hotez, that more than one-quarter of 

pregnant women in sub-Saharan Africa have hookworms, go into 

labor, and deliver profoundly anemic infants. If you could speak to 

the impact it is having on the women themselves in terms of morbidity and mortality for those women. 

You did say—and the number is astonishing—schistosomiasis 

malaffects 100 million girls in sub-Saharan Africa and young 

women. 

And you also mentioned, I think all of you perhaps referenced it, 

but you did especially, the Global Fund. We had Mark Dybul, the 

executive director, the former AIDS czar for George W. Bush, before us. I wish we had this hearing first because I would have 

asked him, but we will follow up with him. What is the Global 

Fund doing on this? 

You know, you mentioned the 3–4 percent increase in acquiring 

HIV/AIDS. It may be Africa’s most important co-factor in the HIV/

AIDS epidemic. How many times have we had PEPFAR hearings, 

and we don’t hear that, but you have brought it to this committee. 

Dr. HOTEZ. Yes, indeed. I mean, there are a couple of issues. 

So, first of all, these are the most common diseases of girls and 

women on the planet. And, I think we often don’t think about neglected tropical diseases as a girls’ and women’s issue; everyone 

talks about how we can address the plight of girls and women living in poverty and how we are going do it. This is how you do it. 

This is the cheapest way to do it and have the greatest bang for 

your buck, point number one. 

Point number two, Mark Dybul is a wonderful man. When we 

worked with the Bush administration on getting those funds appropriated through USAID, it was Mark Dybul who was providing a 

lot of the conduits. So he gets it, he understands the importance 

of neglected tropical diseases. 

That is not the issue. The problem is these big organizations, 

whether it is PEPFAR or whether it is the Global Fund to Fight 

AIDS, TB, and Malaria, tend to get very siloed because it is everything we can do to keep up with their current agreements. So, 

when you go to them and you say, guys, you have to take on neglected tropical diseases, they just look and sigh and say, ‘‘We 

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know, Peter, but, I mean, we are so buried right now, how we going 

do it?’’

And, so I don’t know how we enable PEPFAR and the Global 

Fund to take it on. You know, they are exhausted, amazing public 

servants and really smart people. We have good people that work 

in PEPFAR, good people that work in USAID, good people that 

work in the Global Fund to Fight AIDS, TB, and Malaria. And I 

think this could be an important role for Congress, is to help that, 

help facilitate that process. But it has to be done. 

Mr. SMITH. Dr. Siegel, you mentioned three very specific recommendations. Is that something that would lend itself to putting 

into a bill, or could it just be done by admonishing the current administration and other governments and NGOs do more? 

Dr. SIEGEL. I think a lot of what can be done and needs to be 

done would not require legislation, although I won’t say that I have 

a lot of expertise in this area. 

So one of the areas, of course, in my testimony, particularly the 

written testimony goes into significant length about, is establishment of different mechanisms, systems, partnerships that would 

create either incentives or facilitate investment from not just industry but private foundations, other parties, private investors, to 

help address this problem. 

A lot of that work, I think, does not require legislation. I think 

congressional support, exhortation, increased involvement, and perhaps increased funding for involvement from public health agencies 

and the Department of Defense can all play an important role in 

making that happen. And I think Congress can really, you know, 

stimulate those sorts of actions. There might be some areas and 

some types of investment scenarios that would require legislation, 

though. 

Mr. SMITH. Yes, Dr. Hotez? And, Dr. Hotez, do you think that a 

centerpiece of a neglected diseases bill, tropical diseases, would be 

these ‘‘Centers for Excellence’’? 

Dr. HOTEZ. So the ‘‘Centers of Excellence’’ would be a key component, you know, both to focus on neglected tropical diseases abroad 

as well as here. 

So what we are seeing is a blurring; it is wherever poverty exists. 

In fact, I have this new provocative map that was just published 

in Foreign Policy about where the neglected tropical diseases are, 

and it is those pockets of intense poverty in G–20 countries—northeastern Brazil, southern Mexico. And right there is the southern 

United States, with Texas and elsewhere and the Gulf Coast. So 

that is point one. 

I think point two is—and I have written about this—we need to 

set aside a portion of the President’s Global Health Initiative, it 

could be just 1–2 percent, for new product R&D. I think that would 

be a real game-changer. That would put a lot of support into the 

system and to make that happen. So that is a key component. 

And I think, lastly, we need to really look at these diseases as 

girls’ and women’s issues and think about, when we talk of addressing women’s health, ask, what are we doing about the neglected tropical diseases? I think that is extremely important. 

And, finally, I will just say, NIH, you know, the leadership of 

NIH, including Roger Glass at Fogarty, Tony Fauci at NIAID, have 

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really bent over backwards to keep NTDs on the radar screen, oftentimes against political pressure. We really have to congratulate 

them for their leadership. 

The other thing we are not doing, though, is we are not supporting our military. We are not supporting the Walter Reed Army 

Institute of Research. We are not supporting the Navy equivalent. 

We often forget, many of these products that everyone talks 

about for scaling up were actually invented by the U.S. military. 

One of the reasons why we initially set up in Washington, DC, is, 

how do you learn how to make a vaccine in a nonprofit sector? 

Well, we do it through learning from—people from Walter Reed 

Army Institute of Research have been our teachers. 

They are dying on the vine right now because they are not being 

provided any funding, even though they have one of the greatest 

track records in leadership. We have an article talking about the 

role of military leadership in tropical disease coming out in the fall. 

Mr. SMITH. We had a representative from Walter Reed testify on 

malaria just a few weeks. But true to form, because, you know, he 

is a good—he knows the border——

Dr. HOTEZ. Yeah, they can’t say it. That is why I have to say it. 

Mr. SMITH. I asked him, what do you need? How can we be helpful? And he was very creative in how he answered; well, we are 

doing the best we can with what we have. 

Dr. HOTEZ. You know, Walter Reed is one of our greatest national treasures. And we are not doing either the military or our 

U.S. citizens a service by cutting them short. 

Dr. SIEGEL. Chairman Smith? 

Mr. SMITH. Yes? 

Dr. SIEGEL. I just want to get back to your earlier question and 

say that I would like to take the opportunity to consult with a 

broader range of experts, because there is a lot that can be done 

without further legislation, but there is also a lot, potentially, 

where legislation would be helpful. And we would be pleased to——

Mr. SMITH. If you could help us craft a bill. I find sometimes 

when you get a bill passed in the House, even if it doesn’t pass the 

Senate, it does have an impact. 

Some years ago, I introduced a bill to deal with obstetric fistula. 

And I visited a hospital which many people have visited in Ethiopia that has worked miracles on women who suffer from that horrible, disfiguring, and debilitating outcome from obstructed delivery 

and other reasons. 

And we got the bill passed in the House. The Senate never took 

it up. I asked USAID if they would just follow the parameters. 

They had the authority to do what the bill had recommended. And 

Kent Hill, who was then the USAID health official, the top guy, he 

did it. And 20,000 obstetric fistula surgeries so far have been performed via USAID dollars, augmenting what the Africans are 

doing, what everyone else is doing, including that great hospital in 

Ethiopia. 

So, you know, any ideas you have, we will work hard to get it 

enacted into law when we get a, you know, tropical disease——

Dr. HOTEZ. That is so reassuring. And we are not talking billions. We are not even talking hundreds of millions. We are talking 

very modest amounts that can be transformational. 

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Mr. SMITH. Please give us your best ideas on what it should look 

like. And we work very collaboratively, obviously, with our folks 

over at the State Department, USAID, NIH, and CDC. But best 

ideas, please, fork them over. 

Dr. Zwane, did you want to comment, particularly on the Dalits 

issue? Are they mostly——

Ms. ZWANE. Oh, yes. On the issue of who has worms in India, 

the first thing I would say is there is a lot we don’t know about 

that. Unlike in Africa, where quite a bit of mapping has been done 

to understand where the worms are, we know relatively less about 

that in South Asia. 

A highly catalytic investment would be to systematically map 

India for the likelihood of soil-transmitted helminth infections, 

which would cost something on the order of $8 million to $10 million and wouldn’t be, you know, from the—maybe I am an ex-Gates 

Foundation person, but that is not a lot of money in the grand 

scheme of things. 

But what we do know even without that systematic map of India 

is that the worms are a problem of rural poverty. So there are 

fewer worms even amongst the poor in urban settings. And where 

there is lack of sanitation is where there are a lot of worms. So, 

you know, without saying I have the perfect maps that would satisfy Dr. Hotez or CDC, the primary maps are concentrated amongst 

the poor in the Hindi Belt, so Bihar, Rajasthan, that area of India. 

Mr. SMITH. The two Millennium Development Goals, one dealing 

with reducing maternal mortality and also infant mortality—again, 

getting back to your statement, Dr. Hotez, about the anemic infants, is there any number of how many of those children, because 

they are born prematurely and anemic, actually die or suffer from 

other diseases that would reduce their quality of life? 

Dr. HOTEZ. Well, again, this is one of the reasons why neglected 

tropical diseases have been neglected. With some exceptions, most 

of these are not killer diseases. So none of the children are dying 

from the diseases that Dr. Zwane talked about or I talked about. 

But they are no longer wage-earning, productive individuals. 

And, so what needs to be done is to aggressively scale up things 

like deworming, but we are going to need new interventions. So 

you talk about the fact that you don’t know how long we are going 

to have to treat for; it depends. So for that horrific limb-disfiguring 

disease, four or five yearly treatments can actually eliminate the 

disease as a public health problem. We are talking pennies a year. 

So incredible. 

For some of the intestinal worms, like hookworm, they keep coming back. So what we are doing at Sabin Vaccine Institute through 

Texas Children’s and Baylor is we are making a hookworm vaccine. 

The idea is that you fold this in, so after you vaccinate, they don’t 

come back. 

Now, the key is, it has to be a cheap vaccine, right? So our economists tell us that we have to make these vaccines under $2 a dose. 

So it is a very fascinating process of how we make vaccines. We use 

the cheapest inexpensive expression vectors, column resins that 

have been off-patent for years. Because we know we can make a 

vaccine for hundreds of dollars; the trick is doing it for $2. And I 

think we are succeeding in that, and now it is in clinical trials. 

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Mr. SMITH. Do they require a cold chain? 

Dr. HOTEZ. Well, right now our vaccines require a cold chain. It 

would be nice if we can factor that out, as well. But for version 1.0 

of our vaccines, we still need a cold chain. 

Ms. ZWANE. Just to follow up on that with respect to very young 

children, the drug donation program and the program—please correct me if I say anything incorrect—as overseen by WHO focuses 

on primary-school-age children. But we know that, in fact, children 

who are 1 year old or certainly 2 years old also may very well often 

have worms. But the drug donation program does not provide 

drugs for those children. 

So if we want to work with a country government to expand 

treatment down, getting into that 1,000-days period, then they 

themselves have to purchase the drugs, which changes the cost, the 

calculus of the program and the complexity of the program significantly. Expanding our conversation around how to handle children 

under primary-school age could also be something quite valuable. 

Dr. SIEGEL. That is true, and that is one of the—we are actually 

investing some number millions of the dollars in the development 

of chewable, as I mention in my testimony, a chewable version of 

mebendazole. And one of the main reasons is in order to be able 

to bring that down and make it more accessible to younger children. 

Dr. HOTEZ Yes, one of the things that has been found now which 

is very curious is that we are seeing high rates of hookworm infection in young neonates, as well. There is some suggestion that the 

neonates are acquiring it vertically through breast milk, that the 

women are infected, the larvae get into breast milk, and it is being 

transmitted vertically from mother to child. 

So we are finding all these new mother-to-child NTDs. So, for instance, maternal-child Chagas disease, we are finding it is transmitted from mother to baby. And it is, we estimate, 300,000 pregnant women in Latin America with Chagas disease. Researchers at 

Tulane have estimated 40,000 pregnant women in North America 

alone with Chagas disease, transmitting it from mother to baby 

around 5–10 percent of the time. 

We have nothing to offer those pregnant women, because the 

medicines that are used to treat Chagas disease, like many of the 

NTDs, they are basically poisons. And you hope you can poison the 

parasite before you poison the person who is getting the medicine. 

These medicines were developed in the Pleistocene era, right? They 

were developed a long time ago, and we need to do better. 

So organizations like ours, Sabin Vaccine Institute, and Texas 

Children’s and Baylor College of Medicine, their National School of 

Tropical Medicine, are making vaccines. And then you have very 

exciting drug product development partnerships like DNDI, the 

Drugs for Neglected Disease Initiative, Institute for OneWorld 

Health working on the small molecule. And then, together, we 

think we want to create a whole portfolio of these products that can 

be made. 

Mr. SMITH. Real quick, two final questions. How many total people are malaffected by worms, you know, hookworm, every other 

worm? 

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And, secondly, in treating that one-quarter of pregnant women in 

sub-Saharan Africa who have hookworms, is the treatment injurious to the mother and baby? 

Dr. HOTEZ. So what we do is we treat—we now recommend treating in the second or third trimester. Nobody likes to give the medicine in the first trimester of pregnancy. And it has been shown to 

be extremely beneficial, both to mother and the baby in terms of 

infant survival downstream. 

Total number of people infected, well, wherever you find poverty, 

you find a worm. So we know they are ubiquitous among the 1.3 

billion people who live on less than $1.25 a day. A significant percentage of people live on less than $2 a day. So it would not be an 

exaggeration to say 2 billion people on our planet with worms. 

Mr. SMITH. Do the worms go through the placenta, or is it at 

birth? 

Dr. HOTEZ. Worms, generally speaking, do not go through the 

placenta, but the Chagas disease parasite can go through the placenta. The malaria parasite can go through the placenta. These are 

single-celled organisms that have the ability to do that. 

Mr. SMITH. We are joined by Congressman Meadows, who I know 

had a meeting with the Ambassador from Turkmenistan that prevented him from being here. 

But thank you for joining us. 

Mr. MEADOWS. Thank you, Mr. Chairman. 

And thank each of you. And I came back to show the importance 

of it. Actually, I have a meeting in a few minutes with a head of 

the cabinet from Japan. So I am going to run out. 

Dr. HOTEZ. You can congratulate the Ambassador to Japan if you 

like. They just stepped up and provided the first major contribution 

for neglected disease product——

Mr. MEADOWS. I spoke to him——

Dr. HOTEZ. It is a partnership with Japanese industry. 

Mr. MEADOWS [continuing]. And it is a wonderful partnership, 

and we have a great relationship. So I will pass that on to him. 

But I want to just say thank you for highlighting this. And the 

chairman is correct; when we highlight things, it may not pass in 

legislation, but we do see a difference, truly, in terms of other programs that are discretionary in terms of where those dollars go. 

And so your testimony today is very key and very apparent in 

terms of making real changes. 

I would ask each of you, but specifically Dr. Siegel, if you will 

get back to us in terms of legislative tweaks or legislative initiatives that we can look at. And I will work with the chairman in 

terms of putting forth and working hard to make that a reality. 

The other thing that I would ask, not necessarily for you to comment, unless you have strong comments on that today, is with regards to this 40 percent, where we are talking about a 40 percent 

reduction in terms of mental capacity or economic benefit, that is 

huge because there are those that will sign on to a piece of legislation based on the humanitarian aspect of it, but there is another 

group that will sign on based on the economic benefit. 

And what we are seeing is we are having to spend major economic dollars to go into these countries in Africa and Central Asia 

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and other places, that we could hopefully reduce our long-term economic support if we increase that ability. 

And so I would really like, if you would, to focus on that, where 

we can put together a model that——

Dr. HOTEZ. We can pull together all the numbers from the different counties—India loses $1 billion a year in economic losses 

from lymphatic filariasis. We have now collected all those numbers 

in one repository. We can provide that. When we provide information on the legislation, we will be happy to provide this data—and 

it is the same in the U.S. These diseases are trapping people in 

poverty in the U.S. 

Mr. MEADOWS. Well, and it is not the whole story. I mean——

Dr. HOTEZ. The humanitarian piece is important, but you are absolutely right, this is enlightened self-interest. 

Mr. MEADOWS. Well, I appreciate it. And I am going to have to 

run, but I wanted to come and say thank each of you. 

Thank you, Mr. Chairman, for once again being a great voice. I 

yield back. 

Mr. SMITH. Thank you, Mr. Meadows. 

Is there anything you would like to add before we conclude? 

Dr. HOTEZ. Just to thank you for your leadership. And, you 

know, as we often say, we need leaders in Congress to take the ‘‘N’’ 

out of ‘‘NTD.’’ And I am profoundly appreciative. 

Dr. SIEGEL. Again, I also want to thank you. 

And, you know, it was interesting that we heard earlier from perhaps some younger members, but I lived through seeing the impact 

the Orphan Drug Act had, and so you don’t need to sell me on the 

importance that legislation but also—and the reason for my comment earlier was, just congressional attention to an issue can make 

a big difference, as well. 

So thank you very much, and we will get back with further 

thoughts. 

Ms. ZWANE. Thank you very much. 

Mr. SMITH. Thank you. 

We will use this hearing and your tremendous contributions to 

combating these horrible diseases to launch what I hope will be a 

significant bill. We will look to make it totally bipartisan and look 

for some friends over on the Senate side to do likewise, but we 

need your input. 

And I would say, Dr. Hotez, in the early 1980s, I traveled with 

Dr. Sabin to El Salvador when they had a ‘‘day of tranquility.’’ The 

FMLN and President Napoleon Duarte’s government, at the behest 

of Jim Grant from UNICEF, actually had a day or days of tranquility. They vaccinated about 200,000 kids. Nobody knows the 

exact number, but it was incredible. And everywhere we went to 

the vaccination sites, kids got the vaccinations for pertussis, diphtheria, and other diseases, but they also got the drops for polio. 

And it was amazing to see. 

I was back there at a conference on trafficking, combating 

human trafficking, about 4 years ago. And I looked around, and everybody in the audience seemed to be the age that they were little 

tikes, little children when I was there before. And I said, I bet you 

I met some of you 25 years ago, in a different setting of course. 

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Dr. HOTEZ. And we shouldn’t underestimate American technology 

and its role as Ambassadors. And how do we project power? Well, 

I think a lot of it has to do with what we are doing for these infectious and neglected diseases. 

Mr. SMITH. I couldn’t agree more. 

Thank you so much. 

The hearing is adjourned. 

[Whereupon, at 5:10 p.m., the subcommittee was adjourned.] 

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